MAUDE Adverse Event Report: MICROVENTION, INC. FRED 27; FLOW DIVERTER

Model Number	FRED4017-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Thrombosis/Thrombus (4440)
Date of Event	03/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance's associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identifies thromboembolic events and hemiplegia as potential complications associated with use of the device.
Event or Problem Description
It was reported that after implantation of a fred stent to treat a 4.7mm right superior hypophyseal artery aneurysm, a 2.4mm right lateral paraclinoid internal carotid artery (ica) aneurysm, and a 2.4mm right cavernous ica aneurysm, the patient awoke from anesthesia and began to experience a ten minute episode of left arm and left leg weakness.A ct showed no hemorrhage and cta showed no large vessel occlusion.There was no thrombus identified in the patient, but the physician did deem it to be a thromboembolic event.The patient's platelet reactivity units (pru) were measure at 189 and their ticagrelor dose was increased to 180mg, after which the symptoms resolved.The patient remains neurologically intact one year after treatment.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11520817
• Report Number: 2032493-2021-00079
• Device Sequence Number: 3844474
• Product Code: OUT
• UDI-Device Identifier: 00842429106730
• UDI-Public: (01)00842429106730(11)190318(17)220228(10)19031854ZM
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: FRED4017-PMA
• Device Lot Number: 19031854ZM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR